| CTRI Number |
CTRI/2025/04/085870 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral Other (Specify) [Diabetes Self mnagement Coaching] |
| Study Design |
Other |
|
Public Title of Study
|
effect of Diabetes self management coaching on glycemic control |
|
Scientific Title of Study
|
Effect of Center and Voice call based Diabetic Self Management Coaching(CV-DSMC) on clinical and behavioral outcome among elderly people with type 2 diabetes at KMCH RHTC Vagarayampalayam coimbatore India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MALARKODI M |
| Designation |
Professor |
| Affiliation |
KMCH COLLEGE OF NURSING |
| Address |
ROOM NO 218
Department of Community health nursing
KMCH college of nursing
KMCH COLLEGE OF NURSING
Phase II,balagi nagar
kalapati road
coimbatore Coimbatore TAMIL NADU 641048 India |
| Phone |
9361140010 |
| Fax |
|
| Email |
malarkodi@kmchcon.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.S.ARUNA |
| Designation |
Professor & HOD |
| Affiliation |
Sriramachandra Insistute of Higher education and Research |
| Address |
Room No.115
Department of Community health nursing
Sriramachandra Faculty OF NURSING, Sriramachanda Faculty of Nursing,SRIHER(DU),
Porur
600116 Chennai TAMIL NADU 600116 India |
| Phone |
9444412607 |
| Fax |
|
| Email |
aruna.s@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
MALARKODI M |
| Designation |
Professor, |
| Affiliation |
KMCH COLLEGE OF NURSING |
| Address |
Room no 218
Department of Community health nursing
KMCH COLLEGE OF NURSING, KMCH COLLEGE OF NURSING,PHASE II,BALAJI NAGAR, KALAPATTY ROAD,
kalapatti ,coimbatore Coimbatore TAMIL NADU 641048 India |
| Phone |
9361140010 |
| Fax |
|
| Email |
malarkodi@kmchcon.ac.in |
|
|
Source of Monetary or Material Support
|
| KMCH RURAL HEALTH CENTER -STUDY CENTER,VAGARAYAMPALAYAM,COIMBATORE,TAMILNDU 641659. |
|
|
Primary Sponsor
|
| Name |
MALARKODI M |
| Address |
KMCH college of Nursing
kalapatti post coimbatore-48 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrJeevithan |
KMCH RURAL HEALTH CENTER |
ROOM NO.10, OUT PATIENT DEPARTMENT,Vagarayampalayam, Tamil Nadu 641659 Coimbatore TAMIL NADU |
9965570174
dr.jeevithan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
diabetes self management education |
The intervention will be delivered in two phases
Phase I- Centre based Coaching
Phase II- Voice call Coaching
Education session, Practical Demonstration (1 hr/session- 4 weeks)-, Reinforcement-I(2 months), Reinforcement-II (2 months)
10- to 20min voice call coaching sessions will be given bimonthly for first 2 months. Monthly once voice call coaching will be given for next 2 months.
|
| Comparator Agent |
only education session will conducted |
patients will be receiving usual care and education is given.reinforcement and voice call coaching will not be provided |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with type 2 diabetes with a duration of 5 years
2.Patients with HbA1c more than 8
3. Aged between 60-80 years and Patients of both sex
4.Patient with symptoms of neuropathy with confirmed type 2diabetes
5.An average daily Neuropathy pain score more than4
|
|
| ExclusionCriteria |
| Details |
1. Patients who are having Plantar ulcers and foot problems
2.Patients with hearing deficit
3.History of Orthopedics complications
4.Patients with chronic kidney disease
5.Patients with other skin disease
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c |
6month and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compliance to treatment |
9 months |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - result of the study
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 10-06-2026 and end date provided 03-02-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
INTERVENTION Centre and Voice call based (CV –DSMC) Diabetes Self-Management Coaching The intervention will be delivered in two phases Phase I- Centre based Coaching Phase II- Voice call Coaching Centre based coaching is categorized into 2 types :1) Educational, which refers to interventions in which patients with diabetes mellitus primarily receive information from the researcher, focusing on the provision of information to improve patients’ knowledge of diabetes self-management.Face to face education will be imparted by the researcher through a prerecorded laptop assisted lecture and discussion method using visual aids like charts and pamphlet in group sessions of four hours, split in to four teaching sessions of 30 minutes each. A total of 20 groups with 6 to 7 patients in each group will be grouped for the education sessions. The content of the education includes diabetes mellitus, short term and life-threatening complications of diabetes, long term concerns, other health issues of diabetes mellitus, principles of diabetes management self-care in diabetes mellitus, planning diet and the way forward. Educational intervention total 2 hrs( 1/2 hr/session- 4 weeks) 2) Behavioral, which refers to the interventions targeting improved self-management behaviors, with a focus on active skills training and emphasizing change in skills and/or lifestyle associated with the implementation of a diabetes self-management regimen, such as diet, physical activity, blood glucose monitoring, adherence to medication and application of virgin coconut oil. Foot care ,foot ankle exercise and foot massage will be demonstrated The samples will be asked to do return demonstration and correction will be given on timely manner Behavioural intervention & Demonstration -total 2 hrs (1/2 hr/session- 4 weeks) Reinforcement-I( 1 hr/week- 8 week Reinforcement-II (1 hr/week -8 weeks) Post test I at 6months Phase II- Voice call Coaching The participants will be offered 10- to 20-min voice call coaching sessions will be bimonthly for four sessions within first 2 months and two sessions within last 2 months. The coach ask each patient to create one specific behavior goal related to physical activity, healthy diet, medical adherence, and/or regular blood glucose monitoring to be addressed during the first 3 months of the study. If a patient have more than one behavior change target, the coach will ask he or she to prioritize the goals and then, together, they address one subject per coaching session. At the end of each coaching session, the coachee need to discuss the time, and agenda of the next coaching call with the coach. During each voice call coaching session, the participant is reviewed his or her work in the previous 2 weeks with respect to the self-selected behavior goal and action plan, and then create a new goal or modify existing goals. If a goal is not achieved, the coach help the participant identify and make a plan for overcoming barriers to achieving the goal. Post test I and II will be carried out after 6 months and 10months respectively. |